Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)

NCT ID: NCT02921035

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

594 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-07-27

Brief Summary

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This is an open label, non randomized, uncontrolled, multicenter, single arm observational study. In this study, the enrolled subjects will be treated with Rebif human serum albumin (HSA)-free formulation (with or without RebiSmart) 44 microgram (mcg), subcutaneous (sc), thrice in a week (tiw) for 24 months.

Detailed Description

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Conditions

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Relapsing Multiple Sclerosis (RMS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Relapsing Multiple Sclerosis (RMS) group

Subjects diagnosed with RMS who are prescribed Rebif (Interferon beta-1a)

Rebif (Interferon beta-1a)

Intervention Type DRUG

Rebif will be administered at a dose of 44 mcg, sc, tiw.

Interventions

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Rebif (Interferon beta-1a)

Rebif will be administered at a dose of 44 mcg, sc, tiw.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects aged more than or equal to (\>=) 18 years and less than or equal to (\<=) 60 years at the time of Rebif introduction
* Subjects diagnosed with RMS according to the revised McDonald criteria (2010)
* Treatment naïve or subjects on other DMDs who will switch to Rebif.
* Subjects will receive 1st Rebif 44 mcg dose after signing informed consent
* Subjects willing and able to provide signed informed consent.

Exclusion Criteria

* Have any contraindications to treatment with IFN beta-1a sc according to European summary of product characteristics (EU SPC)/prescribed information
* Subjects participating in other clinical studies/trials
* Any female subject of childbearing potential who is not on contraceptives
* Subjects refusal to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono Middle East FZ LLC

INDUSTRY

Sponsor Role collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merck Serono Middle East FZ-LLC

Role: STUDY_DIRECTOR

an affiliate of Merck KGaA, Darmstadt, Germany

Locations

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Algiers, , Algeria

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Annaba, , Algeria

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Blida, , Algeria

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Oran, , Algeria

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Sétif, , Algeria

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Tizi Ouzou, , Algeria

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Mendoza, , Argentina

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Rosario, , Argentina

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San Miguel de Tucumán, , Argentina

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Manama, , Bahrain

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Sofia, , Bulgaria

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Al Mansurah, , Egypt

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Alexandria, , Egypt

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Cairo, , Egypt

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Cairo, , Egypt

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Esztergom, , Hungary

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Isfahan, , Iran

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Tehran, , Iran

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Kuwait City, , Kuwait

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Beirut, , Lebanon

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Beirut, , Lebanon

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Casablanca, , Morocco

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Fés, , Morocco

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Marrakesh, , Morocco

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Rabat, , Morocco

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Rabat, , Morocco

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Rabat, , Morocco

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Gdansk, , Poland

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Katowice, , Poland

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Lodz, , Poland

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Lublin, , Poland

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Rybnik, , Poland

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Warsaw, , Poland

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Dammam, , Saudi Arabia

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Jeddah, , Saudi Arabia

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Khober, , Saudi Arabia

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Riyadh, , Saudi Arabia

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Seoul, , South Korea

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Countries

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Algeria Argentina Bahrain Bulgaria Egypt Hungary Iran Kuwait Lebanon Morocco Poland Saudi Arabia South Korea

References

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Al-Roughani R, Zakaria M, Cupler EJ, Taha K. Adherence to subcutaneous interferon beta-1a treatment among patients with relapsing multiple sclerosis: the MAIN-MS study. Front Neurol. 2023 Nov 28;14:1257455. doi: 10.3389/fneur.2023.1257455. eCollection 2023.

Reference Type DERIVED
PMID: 38090266 (View on PubMed)

Related Links

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Other Identifiers

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MS200136_0035

Identifier Type: -

Identifier Source: org_study_id

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